Safety Coated Aspirin 81 mg Low Dose

Description

PHARBEST is a low-dose aspirin regimen containing 81 mg of aspirin per tablet, classified as a nonsteroidal anti-inflammatory drug (NSAID). Each bottle contains 1000 enteric-coated tablets, designed to minimize gastrointestinal irritation. The product is manufactured in the USA and is comparable to the active ingredient found in Bayer® Low Dose. It is important for users to consult with a healthcare provider before initiating use, particularly for heart-related health considerations. The National Drug Code (NDC) for this product is 73057-356-11.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains, as well as for other uses as recommended by a healthcare professional. Due to its delayed action, this product is not suitable for the immediate relief of headaches or other symptoms requiring prompt alleviation.

Healthcare providers are encouraged to discuss additional potential uses of this product with their patients. There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Patients should take the medication with a full glass of water to ensure proper administration and absorption.

For adults and children aged 12 years and older, the recommended dosage is 4 to 8 tablets every 4 hours. The total daily dosage must not exceed 48 tablets within a 24-hour period unless otherwise directed by a healthcare professional.

For children under 12 years of age, it is advised to consult a physician for appropriate dosing recommendations.

Contraindications

Use of this product is contraindicated in individuals with a known allergy to aspirin or any other pain reliever or fever reducer. Additionally, it should not be administered to patients who have previously experienced an allergic reaction to this product or any of its components.

Warnings and Precautions

Patients should be advised of the following warnings and precautions associated with the use of this product.

Reye's Syndrome Children and teenagers who are experiencing or recovering from chickenpox or flu-like symptoms should not use this product. If any changes in behavior accompanied by nausea and vomiting occur during use, it is imperative to consult a physician, as these symptoms may indicate the onset of Reye's syndrome, a rare but serious condition.

Allergy Alert Aspirin may induce severe allergic reactions, which can manifest as hives, facial swelling, asthma (wheezing), or shock. Healthcare professionals should monitor patients for these symptoms and advise them to seek immediate medical attention if they occur.

Stomach Bleeding Warning This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of this adverse effect is increased in patients who:

• Are aged 60 years or older

• Have a history of stomach ulcers or bleeding disorders

• Are concurrently using blood-thinning medications (anticoagulants) or steroid drugs

• Are taking other medications that contain NSAIDs (including aspirin, ibuprofen, naproxen, or others)

• Consume three or more alcoholic beverages daily while using this product

• Exceed the recommended dosage or duration of use

General Precautions Healthcare providers should advise patients to consult a physician prior to use if any of the following conditions apply:

• The patient has a history of stomach problems, such as heartburn

• The patient has high blood pressure, heart disease, liver cirrhosis, or kidney disease

• The patient is taking diuretics

• The patient has asthma

Additionally, patients should be encouraged to seek guidance from a doctor or pharmacist if they are currently taking prescription medications for gout, diabetes, or arthritis.

Emergency Medical Help In the event of an overdose, patients should seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222.

Discontinuation of Use Patients should be instructed to stop taking the product and contact a healthcare professional if any of the following occur:

• Signs of an allergic reaction, which require immediate medical attention

• Symptoms indicative of stomach bleeding, such as feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain

• Worsening pain that lasts longer than 10 days

• Fever that worsens or persists for more than 3 days

• Presence of redness or swelling

• Onset of any new symptoms

• Ringing in the ears or loss of hearing

Side Effects

Patients using this product should be aware of several serious adverse reactions associated with its use. Reye's syndrome is a rare but serious illness that may occur in children and teenagers who have or are recovering from chickenpox or flu-like symptoms. If patients experience changes in behavior accompanied by nausea and vomiting while using this product, they should consult a doctor immediately, as these symptoms could indicate the onset of Reye's syndrome.

Aspirin, the active ingredient in this product, may also cause severe allergic reactions. Symptoms of such reactions can include hives, facial swelling, asthma (wheezing), and shock. Patients should seek immediate medical attention if they experience any signs of an allergic reaction.

Additionally, this product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of this adverse reaction is increased in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, consume three or more alcoholic drinks daily while using the product, or exceed the recommended dosage or duration of use.

Patients are advised to stop using the product and consult a doctor if they experience any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Other reasons to seek medical advice include worsening pain lasting more than 10 days, fever lasting more than 3 days, presence of redness or swelling, occurrence of new symptoms, or symptoms such as ringing in the ears or loss of hearing.

Before using this product, patients should consult a doctor if they have a history of stomach problems, such as heartburn, or if they have high blood pressure, heart disease, liver cirrhosis, or kidney disease. It is also important to inform a healthcare provider if they are taking diuretics or prescription medications for gout, diabetes, or arthritis.

Drug Interactions

Patients taking anticoagulants or steroid medications should exercise caution when using this drug, as there may be an increased risk of bleeding or other adverse effects. It is advisable for these patients to consult with a healthcare professional prior to initiating therapy.

The concomitant use of this drug with nonsteroidal anti-inflammatory drugs (NSAIDs), including prescription and nonprescription options such as aspirin, ibuprofen, and naproxen, may enhance the risk of gastrointestinal irritation or bleeding. Patients are encouraged to seek guidance from a healthcare provider before combining these medications.

Additionally, individuals who are on prescription medications for gout, diabetes, or arthritis should consult their doctor or pharmacist prior to using this drug to ensure safe and effective treatment. Monitoring and potential dosage adjustments may be necessary based on the specific medications involved and the patient's overall health status.

No specific interactions with laboratory tests have been identified in the available data.

Packaging & NDC

Below are the non-prescription pack sizes of Safety Coated Aspirin 81 mg Low Dose (aspirin 81mg). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product due to the risk of Reye's syndrome. Healthcare professionals should advise that if any changes in behavior accompanied by nausea and vomiting occur while using this product, a doctor should be consulted, as these symptoms may indicate the onset of Reye's syndrome, a rare but serious condition.

For children under 12 years of age, it is recommended to consult a doctor before use.

Geriatric Use

Elderly patients, particularly those aged 60 and older, may have an increased risk of severe stomach bleeding. It is essential for healthcare providers to exercise caution when prescribing this medication to geriatric patients.

Monitoring for signs of gastrointestinal bleeding is recommended, and dosage adjustments may be necessary based on the individual patient's health status and concurrent medications. Careful assessment of the risks versus benefits should be conducted to ensure the safety of elderly patients receiving this treatment.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. The use of aspirin during the last trimester of pregnancy is particularly cautioned against, as it may lead to adverse effects on fetal outcomes or complications during delivery. Therefore, it is essential that pregnant patients only use aspirin in this period if explicitly directed by a healthcare provider.

Lactation

Lactating mothers are advised to consult a health professional before using this medication. It is particularly important to avoid the use of aspirin during the last three months of pregnancy unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication in lactating mothers.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the severity of the impairment.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use, particularly if they have conditions such as liver cirrhosis. It is essential for these patients to receive appropriate evaluation and monitoring of their liver function to ensure safe use of the medication. Adjustments to dosage may be necessary based on the severity of hepatic impairment, and ongoing assessment of liver function is recommended throughout the treatment period.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Healthcare professionals should advise patients or caregivers to call the Poison Control Center at 1-800-222-1222 for guidance.

Prompt intervention is crucial in managing overdose situations, as timely medical help can significantly influence outcomes. Symptoms of overdose may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific clinical presentation of the patient. Continuous monitoring and evaluation are essential to ensure patient safety and to address any complications that may arise during the course of treatment.

Nonclinical Toxicology

It is especially important not to use aspirin during the last three months of pregnancy unless specifically directed by a healthcare professional, as it may lead to complications for the unborn child or during delivery. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. Patients should be instructed to discontinue use and consult a doctor if they experience any signs of an allergic reaction, and to seek medical help without delay.

Patients should also be informed to stop use and consult a doctor if they notice any symptoms indicative of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, they should be advised to seek medical attention if pain worsens or lasts longer than 10 days, if fever intensifies or persists beyond 3 days, or if there is any redness or swelling. Patients should be encouraged to report any new symptoms that arise, as well as any occurrences of ringing in the ears or loss of hearing.

It is important for healthcare providers to remind patients to consult a doctor before use if they have a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies to them. Patients with high blood pressure, heart disease, liver cirrhosis, or kidney disease should also be advised to seek medical guidance prior to use. Furthermore, patients taking diuretics or those with asthma should consult a doctor before using the product. Lastly, patients should be encouraged to speak with a doctor or pharmacist if they are currently taking prescription medications for gout, diabetes, or arthritis.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a controlled room temperature of 20-25°C (68-77°F). Care should be taken to avoid exposure to excess heat and moisture to maintain product integrity.

Additional Clinical Information

The product is administered orally. Clinicians should advise patients to consult with their doctor or healthcare provider prior to using this product for heart-related conditions. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Safety Coated Aspirin 81 mg Low Dose, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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